Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction

(EAT-GO Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Petros Benias, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Previous surgery, Ascites, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Endoscopic vs Surgical Gastrojejunostomy for Gastric Outlet Obstruction is an effective treatment?

The available research shows that Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is an effective treatment for gastric outlet obstruction. It is considered a safe and minimally invasive option that avoids the complications associated with surgery. Studies indicate that EUS-GJ provides long-term relief without the risk of tumor growth blocking the passage again, and it doesn't interfere with other treatments like chemotherapy. Additionally, EUS-GJ has been shown to be a viable alternative to surgical methods, offering similar benefits with fewer risks. ^{1 2 3 4 5}

What safety data exists for endoscopic and surgical gastrojejunostomy for gastric outlet obstruction?

Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is considered safe and effective for managing gastric outlet obstruction, with studies highlighting its long-term luminal patency and reduced surgical morbidity. It is a minimally invasive alternative to surgical gastrojejunostomy (SGJ), which is effective but associated with higher complication rates. EUS-GJ with lumen-apposing metal stents has shown promising safety and efficacy outcomes in multicenter studies, although direct comparisons with laparoscopic gastrojejunostomy (Lap-GJ) are limited. ^{1 2 3 4 6}

Is Endoscopic gastrojejunostomy (EGJ) a promising treatment for gastric outlet obstruction?

Yes, Endoscopic gastrojejunostomy (EGJ) is a promising treatment for gastric outlet obstruction. It is a minimally invasive option that avoids the complications of surgery and provides long-term relief without the risk of tumor growth blocking the passage again. It also allows patients to eat normally and can be a safer choice for those who might not be in the best health for surgery. ^{1 2 4 5 7}

Eligibility Criteria

Adults over 18 with unresectable or metastatic periampullary malignancies or distal gastric cancer causing severe gastric outlet obstruction. They must be able to undergo general anesthesia, have a life expectancy of more than 2 months, and cannot eat solids (GOOSS Score of 0 or 1). Not eligible if they have abdominal ascites, other GI tract strictures, previous related surgeries, are pregnant, under 18, or can't complete quality of life surveys.

Inclusion Criteria

My doctor expects me to live more than 2 months or I had a failed duodenal stent procedure.

Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)

My cancer cannot be removed by surgery or has spread to other parts.

Exclusion Criteria

I am under 18 years old.

Pregnancy

I have fluid buildup in my abdomen.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic or surgical gastrojejunostomy to treat gastric outlet obstruction

Immediate procedure

1 visit (in-person)

Immediate Follow-up

Participants are monitored for adverse events and quality of life immediately following the procedure

1 week

Daily visits (in-person)

Extended Follow-up

Participants are monitored for safety, effectiveness, and quality of life at various intervals post-procedure

1 year

Visits at 30 days, 3 months, 6 months, and 1 year (in-person)

Treatment Details

Interventions

• Endoscopic gastrojejunostomy (EGJ) (Procedure)
• Surgical gastrojejunostomy (SGJ) (Procedure)

Trial Overview This study is testing two ways to treat blockages at the stomach exit: one group will receive an endoscopic gastrojejunostomy (EGJ), which is less invasive and done through the mouth; another group will get a surgical gastrojejunostomy (SGJ), which involves surgery on the belly. Patients are randomly assigned to either method.

Participant Groups

Group I: Endoscopic gastrojejunostomy (EGJ) Experimental Treatment 1 Intervention

A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.

Group II: Surgical gastrojejunostomy (SGJ) Active Control 1 Intervention

An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.

Endoscopic gastrojejunostomy (EGJ) is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Endoscopic gastrojejunostomy for:

• Gastric outlet obstruction due to malignancies
• Benign gastric outlet obstruction

🇺🇸 Approved in United States as Endoscopic gastrojejunostomy for:

• Gastric outlet obstruction due to malignancies
• Benign gastric outlet obstruction

🇯🇵 Approved in Japan as Endoscopic gastrojejunostomy for:

• Gastric outlet obstruction due to malignancies
• Benign gastric outlet obstruction

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

North Shore University Hospital Manhasset, NY

Long Island Jewish Medical Center New Hyde Park, NY

Lenox Hill Hospital New York, NY

Who Is Running the Clinical Trial?

Northwell Health Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided gastrojejunostomy with a lumen-apposing metal stent: a multicenter, international experience. [2022] Surgical gastrojejunostomy and enteral self-expanding metal stents are efficacious for the management of gastric outlet obstruction but limited by high complication rates and short-term efficacy. Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is a novel alternative option.

2. Australia pubmed.ncbi.nlm.nih.gov

Nasojejunal tube-assisted endoscopic ultrasound-guided gastrojejunostomy for the management of gastric outlet obstruction is safe and effective. [2023] Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is a therapeutic option for patients with gastric outlet obstruction (GOO), which provides long-term luminal patency without the risk of tumor ingrowth and/or overgrowth and avoids surgical morbidity. The goal of this study was to assess technical success, clinical success, and adverse events associated with a nasojejunal tube-assisted EUS- GJ technique.

3. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound guided gastrojejunostomy in the treatment of gastric outlet obstruction: multi-centre experience from the United Kingdom. [2023] Endoscopic ultrasound guided gastrojejunostomy (EUS-GJ) with lumen apposing metal stents has recently emerged as a viable option, as an alternative to surgical gastrojejunostomy and endoscopic enteral stenting, for managing gastric outlet obstruction (GOO). We aim to perform a retrospective analysis of the efficacy, safety and outcomes of EUS-GJ performed at three tertiary institutions in the United Kingdom.

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of pancreatic head cancer with obstructive jaundice by endoscopy ultrasonography-guided gastrojejunostomy: A case report and literature review. [2022] Ultrasonography-guided gastrojejunostomy (EUS-GJ) might be a safe, innovative and minimally invasive interventional treatment for patients with gastric outlet obstruction (GOO) as an alternative to the surgical approach. To date, few cases have been reported in the literature.

5. United States pubmed.ncbi.nlm.nih.gov

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience. [2023] Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO.

6. United States pubmed.ncbi.nlm.nih.gov

EUS-guided Gastrojejunostomy Versus Laparoscopic Gastrojejunostomy: An International Collaborative Study. [2022] Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) with placement of a lumen-apposing metal stent is a minimally invasive and efficacious procedure for gastric outlet obstruction (GOO) patients not amenable to surgery. Laparoscopic gastrojejunostomy (Lap-GJ) has traditionally been the standard of care. No direct comparison between EUS-GJ and Lap-GJ has been described. Our aim was to compare the clinical outcomes, success rate, and adverse events (AE) of EUS-GJ with Lap-GJ.

7. United States pubmed.ncbi.nlm.nih.gov

Palliative therapy for malignant gastric outlet obstruction: how does the endoscopic ultrasound-guided gastroenterostomy compare with surgery and endoscopic stenting? A systematic review and meta-analysis. [2023] The gold-standard procedure to address malignant gastric outlet obstruction (MGOO) is surgical gastrojejunostomy (SGJJ). Two endoscopic alternatives have also been proposed: the endoscopic stenting (ES) and the endoscopic ultrasound-guided gastroenterostomy (EUS-G). This study aimed to perform a thorough and strict meta-analysis to compare EUS-G with the SGJJ and ES in treating patients with MGOO.